Phase 2a Clinical Study to evaluate efficacy and safety of JTE-451 ointment in patients with plaque psoriasis.

JRCT ID: jRCT2031210232

Registered date:06/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Plaque Psoriasis
• Date of first enrollment: 30/08/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): An appropriate amount of JTE-451 or placebo ointment will be applied to the areas affected by plaque psoriasis.

Outcome(s)

• Primary Outcome: Proportion of subjects with >=75% improvement in PASI score from Baseline

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1. Japanese subjects who have clinical diagnosis of chronic plaque psoriasis for at least 6 months and whose disease condition is stable, at informed consent
2. Subjects with a PASI score >=5.0
3. Subjects with a PGA score of 2, 3 or 4
4. Subjects with BSA affected >=3% and <=20% (except for the hairy scalp)

Exclude criteria

1. Subjects with psoriasis other than plaque psoriasis
2. Subjects who have shown no efficacy by treatment with specific biologics
3. Subjects with dermatologic or inflammatory condition that would affect the study assessments determined by the investigator
4. Subjects with acute active bacterial, fungal or viral skin infection

Related Information

• Primary Sponsor: Miwa Yasushi